Kornimate/medical-research-clean huggingface dataset:
spinal versus caudal analgesia after pediatric infra-umbilical surgery

Conditions: Pain, Postoperative

Summary: caudal analgesia along with general anesthesia is a very popular regional technique for prolonged postoperative analgesia in different pediatric surgical procedures where the surgical site is sub-umbilical. caudal anesthetics usually provide analgesia for approximately 4-6 hours. recently, the use of spinal anesthesia in infants and children requiring surgeries of sub-umbilical region is gaining considerable popularity worldwide. - the ease of performance and the safety regarding cardio-respiratory functions makes spinal anesthesia as an alternative to general anesthesia in infants and children undergoing surgeries of sub-umbilical regions.

the historic view that young children neither respond to, nor remember, painful experiences to the same degree as adults is no longer thought to be true. about 40% of pediatric surgical patients experienced moderate or severe postoperative pain and 75% had insufficient analgesia. -pediatric acute pain services use techniques of concurrent or co-analgesia based on four classes of analgesics, namely local anesthetics, opioids, non-steroidal anti-inflammatory drugs (nsaids), and acetaminophen (paracetamol). caudal analgesia along with general anesthesia is a very popular regional technique for prolonged postoperative analgesia in different pediatric surgical procedures where the surgical site is sub-umbilical. caudal anesthetics usually provide analgesia for approximately 4-6 hours. recently, the use of spinal anesthesia in infants and children requiring surgeries of sub-umbilical region is gaining considerable popularity worldwide. - the ease of performance and the safety regarding cardio-respiratory functions makes spinal anesthesia as an alternative to general anesthesia in infants and children undergoing surgeries of sub-umbilical regions.

Eligibility criteria:
inclusion criteria: * age: 2-12 years. * weight: 15-40 kg. * sex: both males and females. * asa physical status: 1-ii. * operation: surgery below umbilicus. exclusion criteria: * allergic reaction to local anesthetics (las). * local or systemic infection (risk of meningitis). * coagulopathy. * intracranial hypertension. * hydrocephalus. * intracranial hemorrhage. * parental refusal. * hypovolemia. * spinal deformities, such as spina bifida or myelomeningocele. * presence of a ventriculoperitoneal shunt because of a risk of shunt infection or dural leak.
gaming apps post-stroke

Conditions: Stroke; Cognitive Impairment; Executive Dysfunction; Cognitive Change; Cognitive Deficit

Summary: the investigators aim to explore the effect of puzzle mobile or tablet-based games on problem-solving impairment resulting from a first-time stroke. this is a randomized-controlled trial with the intervention arm consisting of puzzle gaming applications and the control arm consisting of stroke-relevant educational videos provided and encouraged throughout the course of participants' acute inpatient rehabilitation stay.

study subjects will be randomized to a control or experimental group and allocation will be concealed. the experimental group will consist of the subject utilizing their personal mobile or tablet device to play a pre-selected set of problem-solving games for a goal of 1 hour daily. the control group will utilize their personal mobile or tablet device to perform the non-problem-solving task of watching educational videos of their choice from a pre-selected set of videos for the same amount of time daily. the intervention gaming arm will be provided different gaming apps if they lose interest or find a particular game too easy or too difficult. the control video arm will be provided different educational videos according to their needs that may change throughout their inpatient stay.

Eligibility criteria:
inclusion criteria: 1. age 18-89 2. hospitalized at loma linda east campus rehabilitation hospital 3. first time stroke patient 4. mild to moderate problem-solving impairment without severe deficit in any other cognitive domain on admission speech evaluation 5. have daily access while inpatient to a personally owned apple or android smartphone or tablet device prior to the initial session. exclusion criteria: 1. unable to understand and follow verbal and written instructions in english 2. presence of aphasia that limits device use or ability to provide consent 3. presence of pre-stroke speech, language, or cognitive disorder 4. unable to operate device due to cognitive, physical, or visual impairment

Keywords: stroke cerebrovascular accident
cardiac shock wave treatment in patients with reduced coronary flow reserve

Conditions: Refractory Angina Pectoris; Ischemic Heart Disease; Coronary Artery Disease

Summary: the purpose of the study is to assess the feasibility of cardiac shock wave treatment in patients with anginal chest pain and evidence of abnormal myocardial perfusion under stress in the absence of significant stenoses of the epicardial coronary arteries.

this is a mono-center, prospective, single arm, pilot study designed to assess the feasibility of the "cardiac shock wave treatment" in patients with anginal chest pain and evidence of abnormal myocardial perfusion under stress in the absence of significant stenoses of the epicardial coronary arteries. a total of 10 subjects will be enrolled in the study. all enrolled study subjects will be assessed for clinical follow-up at the following intervals: 5 and 14 weeks post cswt procedure.

Eligibility criteria:
inclusion criteria: * history of anginal chest pain that prompted a myocardial stress test (nuclear myocardial perfusion imaging, stress echocardiography, or perfusion cmr) * evidence for stress-induced myocardial ischemia in this examination * coronary angiogram showing absence of ≥30% stenosis of epicardial coronary arteries exclusion criteria: * participation in other clinical trials * age \<18 years * contraindications to under cmri * contraindications to adenosine (severe chronic obstructive pulmonary disease (copd), asthma, atrioventricular block (av block) \> grade 1) * left ventricular thrombus * uncontrolled diabetes mellitus * uncontrolled arterial hypertension, * any other severe chronic illness such as liver or renal failure (glomerular filtration rate (gfr) \< 45 ml/min), active neoplastic disease, history of myocardial infarction or coronary revascularization within the past three months * patients with pacemaker or implanted cardioverter defibrillator * patients after valve surgical replacement * patients after interventional valve replacement or reconstruction (e.g. transfemoral aortic valve replacement or mitraclip implantation) * pregnancy (a reliable method of contraception must be used for the entire duration of the study) * fertile female participants who are capable of bearing children and who do not use a method of contraception that is medically approved by the health authority of the respective country * missing capacity to consent
dose escalation study of rslv-132 in subjects with systemic lupus erythematosus

Conditions: Systemic Lupus Erythematosus

Summary: a one month multi-dose study will evaluate the safety and tolerability of 3 intravenous infusions of rslv-132 in subjects with inactive to mild sle.


Eligibility criteria:
inclusion criteria: * stable sle with no anticipated change in medications for the next 60 days exclusion criteria: * other biologic drugs

Keywords: rslv-132 systemic lupus erythematosus lupus sle resolve
talar avascular necrosis: surgical angiogenesis vs. core decompression

Conditions: Avascular Necrosis of Bone

Summary: the purpose of this study is to determine if surgical angiogenesis performed in talar avascular necrosis by free microvascular bone grafts from the femoral condyle is a superior technique compared to core decompression and nonvascularized osseous autografts.

the aim of this prospective randomized clinical trial is the comparison of two surgical treatment options for talar avascular necrosis (analogical to ficat and arlet stage ii and iii). the randomized study design allows direct comparability of the outcome after either core decompression and nonvascularized osseous autografting from the iliac crest or core decompression and osseous autografting with a free microvascular medial femoral condyle. talar avascular necrosis is caused by osseous malperfusion leading to malnutrition and destruction of the talar bone. the extend of this malperfusion is variable and can be categorized in 4 stages. the osseous defects can remain without consequences (stage i) or lead to irreversible talar destruction. the current treatment option for stage ii and iii is the core decompression followed by osseous auto grafting from the iliac crest. reducing the intraosseal pressure and filling the drill holes with the bone graft can lead to reperfusion of the talus. a new technique is to fill the drill hole with a vascularized bone graft from the medial femoral condyle, using microvascular anastomosis. this procedure has already been approved for the treatment of avascular necrosis and malperfusion of the carpus (lunate and scaphoid) as well as the femoral head. patients are examined preoperative as well as 3, 6 and 12 month after operation, documenting the active range of motion and pain sensation while resting and on activity. well established scores like the aofas ankle-hindfoot score and the lower extremity functional scale are used to get subjective and objective informations about patients' daily life and postoperative satisfaction. x-rays are taken at the same stages. mris of the ankle joint with contrast agent are performed before as well as 6 and 12 months after surgery. statistical analysis is performed using the statistical package for the social sciences (spss). the study protocol has been approved by the ethics commission of rheinland-pfalz. interventions are done according to the declaration of helsinki.

Eligibility criteria:
inclusion criteria: * avascular talar necrosis stage 2 and 3 (ficat and arlet) * signed patient consent form exclusion criteria: * steroid or chemo therapy * participation in a different study * pregnancy * peripheral artery occlusive disease stage 3 and 4 * avascular talar necrosis stage 1

Keywords: avascular necrosis, talus, medial femoral condyle
pf-07321332/ritonavir and ritonavir on dabigatran study in healthy participants

Conditions: Healthy Participants

Summary: this is a drug-drug interaction study to assess the effects of pf-07321332/ritonavir and ritonavir on the pharmacokinetic (pk) of dabigatran in healthy volunteers. pk will be evaluated for pf-07321332 and ritonavir. dabigatran is being utilized as a p-gp substrate


Eligibility criteria:
inclusion criteria: * body mass index (bmi) of 17.5 to 30.5 kg.m2; and a total body weight \>50 kg (110 lbs) * female participants must have a negative pregnancy test exclusion criteria: * positive test for sars-co-v2 at the time of screening or day -1 * active pathological bleeding or risk of bleeding * positive urine drug test * history of sensitivity to heparin or heparin induced thrombocytopenia * participants who have been vaccinated for covid-19 in the past 7 days

Keywords: drug drug interaction dabigatran p-gp substrate sars-co-v2 covid-19 protease inhibitor ritonavir
ckd-828 telmisartan non-responder trial

Conditions: Hypertension

Summary: the aim of the present study is to evaluate the efficacy and safety of two dose combination of telmisartan/s-amlodipine (40/2.5mg and 40/5mg) compared with telmisartan monotherapy (80mg) in hypertensive patients inadequately controlled by telmisartan monotherapy.


Eligibility criteria:
inclusion criteria: * age 18 years or older * diagnosis of essential hypertension and blood pressure not adequately controlled(inadequate control defined as seated diastolic blood pressure(dbp)\>= 90mmhg if on existing antihypertensive treatment of seated dbp \>= 100mmhg if treatment naive) * failure to respond to four weeks treatment with telmisartan 40mg(failure to respond defined as seated dbp \>= 90mmhg) * willing and able to provide written informed consent exclusion criteria: * mean seated dbp \>= 120mmhg and/or mean seated sbp \>= 200mmhg during run-in treatment or mean seated dbp \>= 120mmhg and/or mean seated sbp \>= 180mmhg at the randomization visit * known or suspected secondary hypertension(ex. aortic coarctation, primary hyperaldosteronism, renal artery stenosis, pheochromocytoma) * has severe heart disease(heart failure nyha functional class 3, 4), unstable angina or myocardial infarction, arrhythmia within the past three months * has cerebrovascular disease as cerebral infarction, cerebral hemorrhage within 6 months * type i diabetes mellitus, type ii diabetes mellitus with poor glucose control as defined by fasting glucosylated hemoglobin(hba1c) \> 8% * nown severe or malignant retinopathy * hepatic or renal dysfunction as defined by the following laboratory parameters: ast/alt \> unl x 2, serum creatinine \> unl x 1.5 * acute or chronic inflammatory status need to treatment * need to additional antihypertensive drugs during the study * need to concomitant medications known to affect blood pressure during the study * history of angioedema related to ace inhibitors or angiotensin ii receptor blockers * known hypersensitivity related to either study drug * history of drug or alcohol dependency within 6 months * any surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of investigational products(ex. gastrointestinal tract surgery such as gastrectomy, gastroenterostomy or bypass, active inflammatory bowel syndrome within 12 months prior to screening, gastric ulcers need to treatment, gastrointestinal/rectal bleeding, impaired pancreatic function such as pancreatitis, obstructions of the urinary tract or difficulty in voiding * administration of other study drugs within 30 days prior to randomization * premenopausal women(last menstruation \< 1year) not using adequate contraception, pregnant or breast-feeding * history of malignancy including leukemia and lymphoma within the past 5 years * in investigator's judgment

Keywords: ckd-828 hypertension primary hypertension s-amlodipine telmisartan amlodipine non-responder
clinical study of gt201 in the treatment of advanced gynecological tumors (advanced cervical cancer)

Conditions: Adult; Gynecological Tumors

Summary: this study is an early exploration clinical study with one arm. the study consists of two stages, namely the dose escalation stage and the dose extension stage:


Eligibility criteria:
inclusion criteria: * 1. the patients (or legally authorized representative) patients (or legally authorized representative) must have the ability to understand the requirements of the study, have provided written informed consent as evidenced by signature on an informed consent form (icf) approved by an institutional review board/independent ethics committee (irb/iec), must have the ability to understand the requirements of the study; * 2.at least one resectable lesion (preferably superficial metastatic lymph nodes) that has not been treated with radiation and has not received other local therapies. the separated tissues mass weighing ≥1.0g (either of single lesion origin or multiple lesions combined) for the preparation of autologous tumor-infiltrating lymphocytes. minimally invasive treatment where possible; exclusion criteria: * 1.the patient who has any active autoimmune disease, history of autoimmune disease, need for systemic steroid hormones or a condition requiring immunosuppressive drug therapy (\>10 mg/day of prednisone or equivalent hormone); * 2. arterial/venous thrombotic events within 3 months prior to enrollment, such as: cerebrovascular accident, deep vein thrombosis and pulmonary embolism occurring; * 3.active infections requiring treatment with systemic anti-infectives (except for topical antibiotics); or those with unexplained fever \> 38.5℃ occurring during the screening period, except for tumor fever; * 4. patients who have received allogeneic bone marrow transplantation or an organ allograft; * 5.patients who have a history of hypersensitivity to any component or excipient of study drugs: autologous tumor infiltrating lymphocytes, cyclophosphamide, fludarabine, il-2, dimethyl sulfoxide (dmso), human serum albumin (hsa), dextran-40 and antibiotics (beta lactam antibiotics, gentamicin);
beliefs, attitudes, and response to genetic testing in sarcomapatients

Conditions: Leiomyosarcoma

Summary: genomic research has shown that a portion of leiomyosarcomas can be attributed to an underlying cancer predisposition syndrome. however, the optimal approach for incorporating germline testing into the care of these patients. this study is assessing the beliefs about the heritability of leiomyosarcoma and other cancer risks, and attitudes towards germline testing among leiomyosarcoma patients.

this is a descriptive study to explore attitudes to genomics and return of genetic information and examine the cognitive and affective impact of receiving germline genetic information among lms patients and their family members.the present study will aim to do the following: * assess leiomyosarcoma (lms) patients' beliefs and attitudes about the heritability of lms and their interest in genetic testing. * among lms patients who undergo genetic testing, evaluate the cognitive, affective, and communication outcomes of genetic testing in lms patients found to have actionable germline germline pathogenic variants (pvs). * evaluate family members' beliefs and attitudes about the heritability of reasons for undergoing genetic testing and responses. prior studies of cancer patients have found a strong interest in genetic testing so at-risk relatives will have the opportunity to have increased cancer screening or take risk-reducing measures to prevent cancer. however, the genes most strongly associated with lms are tumor protein 53 (tp53) gene and retinoblastoma 1 (rb1) gene. these genes cause risks for cancers that families may be less familiar with and that have less well-established approaches for screening and prevention. lms may not be the most significant cancer risk related to the syndrome associated with the pv identified. the finding of risk for other non-lms cancers may be unexpected and incongruent with the family's experience or focus on the lms being treated. screening recommendations for relatives testing positive for these pv will generally be given cancer screening recommendations targeted towards risks for cancers other than lms. patients beginning or in the midst of cancer treatment may be less able to share and effectively communicate about genetic test results to patients. we need to better understand how patients and family members respond to findings to maximize the clinical benefit of this information and support family communication. lms patients will be identified by querying the enterprise data warehouse (edw) and huntsman tumor registry and prospectively by reviewing clinic and tumor board lists.

Eligibility criteria:
inclusion lms proband * actionable germline pv detected in the research context * living * no prior germline testing for this pv * able to speak and read english * mentally competent * age 18 or older relative of lms proband * 25-50% chance for having inherited the pv * no prior germline testing for this pv * able to speak and read english * mentally competent * age 18 or older exclusion (both cohorts) * \<18 years * unable to read or write
microbial study of sublingual immunotherapy tablets in patients with allergic rhinitis

Conditions: Rhinitis, Allergic

Summary: the incidence of allergic rhinitis (ar) in chinese adults was reported to be as high as 24.1% and 16.8% in children. the current symptomatic treatment has the disadvantage of poor efficacy and cannot change the natural course of the disease. allergen immunotherapy (ait) is the only causative treatment approved by the who, bringing a new option to patients with allergic diseases. the quality of allergen preparations is critical to the diagnosis and treatment of the disease, emphasizing the need for standardized preparations, and ait treatment in the early stages of the disease may change the long-term progression of the disease. recent studies have reported that the microbiome of patients with different efficacy of desensitization therapy is different and may be correlated with the clinical symptoms of patients, but no prospective studies have been reported.


Eligibility criteria:
inclusion criteria: * adult patients (18-65 years). * patients with moderate to severe dust mite allergic rhinitis were diagnosed based on clinical history and positive dust mite sensitization tests (skin prick test and/or specific ige). * patients who visited the department of otolaryngology of the first affiliated hospital of nanjing medical university and selected sublingual tablet desensitization. exclusion criteria: * patients who refused to accept specimen and questionnaire collection. * patients who had nasal diseases other than allergic rhinitis, such as nasal papilloma and nasal malignant tumor.
a study of the taste of different oral liquid preparations of cp-690,550 in trained adult product testers

Conditions: Arthritis, Rheumatoid

Summary: this study will test the palatability of several different cp-690,550 oral preparations in trained product tester healthy volunteers.

to develop a palatable pediatric oral solution dosage form of cp-690,550.

Eligibility criteria:
inclusion criteria: * trained healthy non-pregnant product testers, age 18-75 exclusion criteria: * severe acute or chronic medical conditions, including hepatitis or tuberculosis infections or clinically significant laboratory abnormalities.

Keywords: taste study open label investigational drug oral therapy
efficacy of oxepa enteral feeding in ltac (long term acute care hospital) patients on chronic ventilation- a pilot study

Conditions: Acute Lung Injury; Mechanical Ventilation Complication; Dietary Modification

Summary: patients with mechanical ventilation have shown improved weaning rates when enteral tube feeding high in epa, gla and antioxidants were fed to patients in the critical care setting. ltac patients on chronic mechanical ventilation will have decreased days an mechanical ventilation, decreased mortality rates and decreased organ failure when fed an enteral product high in epa, gla and antioxidants compared to an isotonic high fiber enteral nutrition product.


Eligibility criteria:
inclusion criteria: \>18 years old with respiratory failure on mechanical ventilation with failure to wean diagnosis of ards (acute respiratory distress syndrome) bilateral infiltrates - exclusion criteria: history of pulmonary fibrosis, terminal illness/ malignancies, \<28 day life expectancy, hemodialysis, active bleeding or bleeding disorder: dic ( disseminated intravascular coagulation), sickle cell anemia, hemophilia hemorrhagic or ischemic stroke, liver failure, head trauma with glasgow coma scale score of \<5, immunosuppression: wbc(white blood cell count) \<5000, hiv positive, use of immunosuppressant drugs, pregnancy, and heart failure with ef(ejection fraction) \<35% -